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The underestimated value of "clinical benefit" in medical device risk management

In the MDR, the benefit-risk ratio is given a much higher priority than was the case in the MDD. The frequency with which the term benefit-risk occurs in the MDR alone allows this conclusion to be drawn. (27 times "benefit-risk in the MDR vs. 5 times "benefit/risk" in the MDD).

At the same time, "clinical benefit" became a central element as a measure of risk acceptance. The MDR stipulates that [...] any risks associated with their use must be justifiable in terms of benefit to the patient [...]. ((EU)2017-745, Annex I, chap. 1, para. 1)

What is the “clinical benefit”?

By definition, “Clinical Benefit” [...] means the positive impact of a device on the health of an individual, expressed in terms of a meaningful, measurable, patient-relevant clinical outcome(s), including outcome(s) related to diagnosis, or a positive impact on patient management or public health. [MDR, Article 2 (53)]

However, the MDR does not give us a tool with which the clinical benefit can be evaluated.

How can the "clinical benefit" be evaluated?

In order to make the "clinical benefit" assessable and comparable, tangible criteria are needed. Here, CEN ISO TR 24971:202 and an FDA guideline* offer a conclusive approach.

*(Guidance for Industry and Food and Drug Administration Staff: "Factors to consider when making benefit-risk determinations in medical device premarket approval and de novo classifications")

As criteria for assessing the "clinical benefit", the importance of the positive effects of the product on the patient or patient management and the probability of occurrence and duration of this positive effect can be used.

This approach has clear parallels with the criteria for assessing risks.


It can be assumed that many manufacturers of medical devices have not yet evaluated the assessment of "clinical benefit" according to these criteria. The value of the "clinical benefit" for the traceability of the acceptance of risks is still largely underestimated.

Author: Bernhard Lindner

PS: If you would like to learn more about the topic or are looking for support in evaluating the clinical benefit, please do not hesitate to contact us. Our risk management experts will be happy to advise you!


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